目的 探讨参芪肝康片联合恩替卡韦治疗慢性乙型肝炎患者的临床疗效。方法 选取2017年6月—2019年6月于新乡医学院第一附属医院感染科住院治疗的114例慢性乙型肝炎患者作为研究对象，按照住院时间和治疗方式差异随机将患者分为对照组（n=57）和观察组（n=57）。对照组口服抗病毒药物马来酸恩替卡韦片，0.5 mg/次，1次/d。观察组在对照组治疗的基础上口服参芪肝康片治疗，2.1 g/次，3次/d。两组疗程均为6个月。观察两组患者的临床疗效，比较两组治疗前后的肝功能指标、Th17细胞频率、Treg细胞频率、Th17/Treg细胞频率比值、白细胞介素-17（IL-17）、转化生长因子-β（TGF-β）水平以及不良反应发生率。结果 治疗后，对照组和观察组总有效率分别为77.19%和92.98%，两组比较差异具有统计学意义（P<0.05）。与治疗前相比，两组丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、总胆红素（TBIL）水平均显著降低，差异均具有统计学意义（P<0.05）；与对照组相比，观察组治疗后血清ALT、AST和TBIL均显著降低，差异均具有统计学意义（P<0.05）。治疗后，两组患者Th17细胞频率、Th17/Treg细胞频率比值、IL-17水平均显著下降，而Treg细胞频率及TGF-β水平均显著升高（P<0.05）；与对照组相比，治疗后观察组Τh17细胞频率、Th17/Treg细胞频率比值、IL-17水平显著下降，而Treg细胞频率及TGF-β水平均显著升高（P<0.05）。对照组和观察组两组患者不良反应发生率分别为10.53%和14.04%，两组不良反应率相比较无显著差异。结论 参芪肝康片联合恩替卡韦治疗慢性乙型肝炎安全有效，能显著改善肝功能，并降低血清炎症因子水平，可能与影响Th17、Treg细胞频率及降低Th17/Treg细胞频率比值有关。

Objective To investigate the clinical efficacy of Shenqi Gankang Tablets combined with entecavir in treatment chronic hepatitis B. Methods A total of 114 patients with chronic hepatitis B from Xinxiang Medical University between June 2017 to June 2019 were collected. Patients (114 cases) with chronic hepatitis B in the department of infectious diseases, the First Affiliated Hospital of Xinxiang Medical University from June 2017 to June 2019 were selected as the research objects, and the patients were randomly divided into the control group (n=57) and the observation group (n=57) according to the differences in length of stay and treatment methods. Patients in the control group were po administered with Entecavir Maleate Tablets, 0.5 mg/time, once daily. Patients in the observation group were po administered with Shenqi Gankang Tablets on the basis of control group, 2.1 g/time, three times daily. Patients in two groups were treated for 6 months. The clinical efficacy in two groups was observed, and the liver function indicators, Th17 cell frequency, Treg cell frequency, Th17/Treg cell frequency ratio, Il-17, TGF-β levels, and the incidence of adverse reactions before and after treatment were compared in two groups. Results After treatment, the total effective rate in the control group and observation group was 77.19% and 92.98%, respectively, the difference between two groups was statistically significant (P<0.05). Compared with before treatment, the levels of ALT, AST and TBIL in two groups were significantly decreased after treatment, with statistically significant differences (P<0.05). Compared with the control group, the serum levels of ALT, AST and TBIL in the observation were significantly decreased after treatment, with statistically significant differences (P<0.05). After treatment, Th17 cell frequency, Th17/Treg frequency ratio, and IL-17 levels in two groups were decreased significantly, while Treg cell frequency and TGF-β levels were increased significantly (P<0.05). After treatment, compared with the control group, Th17 frequency, Th17/Treg cell frequency ratio, and IL-17 level in the observation group significantly decreased, while the levels of Treg cell frequency and TGF-β were significantly increased (P<0.05). The incidence of adverse reactions in the control group and the observation group were 10.53% and 14.04%, respectively, there was no significant difference between two groups. Conclusion Shenqi Gankang Tablets combined with entecavir in treatment of chronic hepatitis B is safe and effective, which can significantly improve liver function, and reduce the level of serum inflammatory factors, which may be related to the influence of Th17 and Treg cell frequency, and the reduction of Th17/Treg cell frequency ratio.

R975

河南省医学科技攻关计划普通项目（201303106）